Get Certified ISO 7101 Healthcare Management Quality System certification from TUV United Arabia; moreover, achieve it quickly and efficiently for all industries across Saudi Arabia
What is ISO 7101 Healthcare Management Quality System?
Get ISO 7101 certification in Saudi Arabia from TUV United Arabia. ISO 7101 is the international standard for Healthcare Management Quality System (HQMS) developed by ISO and, moreover,serves as a globally trusted benchmark for consistent Healthcare Quality System.
ISO 7101:2023 specifies the essential requirements for establishing a quality management system within any healthcare organization, regardless of its size or type. Consequently, it aims to ensure the delivery of safe, effective, and high-quality healthcare.
In Saudi Arabia, ISO 7101 certification demonstrates commitment to healthcare quality excellence and is often required for government tenders and international business partnerships. As a result, Obtaining the certification strengthens credibility in local and global markets.
Benefits of ISO 7101 Certification for Saudi Organizations Achieving ISO 7101 Certification delivers numerous competitive advantages for businesses operating in Saudi Arabia; moreover, it strengthens credibility and operational efficiency.
Protect Patients from Risks
Moreover, implement systematic controls to prevent medical errors, reduce clinical risks, and enhance patient safety across all healthcare operations.
Enhance Patient Trust
Consequently, demonstrate your commitment to delivering safe, high-quality healthcare services,thereby strengthening patient confidence in the care they receive.
Protect Medical Information
Additionally, secure your organization’s medical records, patient data, and sensitive healthcare information from internal and external threats.
Win International Healthcare Contracts
Furthermore, many global healthcare partners and accreditation bodies require ISO 7101 certification as a prerequisite for collaboration, especially in hospitals, clinics, and medical service providers.
Competitive Advantage
Consequently, differentiate your healthcare organization by demonstrating commitment to world-class healthcare quality and patient-safety practices.
Healthcare Sector Tenders
Additionally, meet requirements for private and public healthcare tenders that specify quality management in healthcare services.
Industries That Need ISO 7101 Certification ISO 7101 certification in Saudi Arabia is universally applicable across all sectors; therefore, organizations from various industries can benefit from its implementation.
Hospitals
such as King Faisal Specialist Hospital & Research Centre and King Abdulaziz University Hospital
Clinics and Outpatient Care Centers
For examples Medical Group and Medical Center
Medical Laboratories
As Laboratories all over the Kingdom
Pharmaceutical and Biotech Companies
Such as Pharmaceutical Industries & Medical Appliances and Pharmaceuticals
Medical Device Manufacturers and Distributors
For examples Supplies medical device and Distributes medical devices
Telemedicine and Digital Health Services
Such as Teleconsultation and patient data management. and Digital health services
Insurance and Health Management Organizations
For examples Health insurance provider and
ISO 7101 certification Structure
ISO 7101 Certification consists of ten main clauses. The first three are introductory, however, clauses 4 to 10 cover the essential requirements of a HQMS.Moreover,The standard follows the Plan–Do–Check–Act (PDCA) cycle, therefore ensuring continuous system improvement.
plan
Clause 4 – Context of the Organization
- Understanding the organization and its context
- Understanding the needs and expectations of interested parties
- Determining the scope of the system and services provided
- Integrating Healthcare Management Quality System
Clause 5 – Leadership
- Top management commitment to leadership and care quality
- Adopting a healthcare quality policy
- Clearly defining roles and responsibilities
- Focusing on patients and service users
- Ensuring access to care
Clause 6 – Planning
- Addressing risks and opportunities
- Setting healthcare quality objectives and planning to achieve them
- Planning for changes and continuous improvement
- Implementing risk management and impact assessment
- Planning for continuity and operational resilience
DO
Clause 7 – Support
- Covers resources required to operate the system:
-
- Human resources
- Infrastructure
- Operational environment
- monitoring and measuring resources
- organizational knowledge
- Competence and training
- Awareness sessions
- Communication
-
Documented information (procedures, forms, records)
- creation and updating
- control of documented information
Clause 8 – Operation
- Efficiently organize and monitor daily operations.
- Safely manage and maintain healthcare facilities.
- Safely dispose of medical and hazardous waste.
- Properly store and handle materials.
- Protect patients’ personal belongings.
- Use modern technologies to improve care.
- Design healthcare services to meet patient needs
- Design healthcare services to meet patient needs
- Ensure quality from external suppliers.
- Deliver safe and effective healthcare services.
- Focus on patient needs and comfort.
- Adhere to ethical principles in healthcare.
- Protect patients from risks and harm during care.
Check
Clause 9 – Performance Evaluation
- Measure system effectiveness
- Collect and analyze data
- Planning and conduct internal audits
- Management review to assess results and make decisions
Act
Clause 10 – Improvement
- Continuous improvement
- Address non-conformities
- Implement corrective actions
- Enhance processes and services continuously
TUV United Arabia ISO 7101 Certification Process
Our streamlined process ensures that you achieve ISO 7101 certification efficiently; moreover, it guarantees effectiveness throughout the process.
1- Internal Readiness Review
Firstly, before submitting the application for ISO 7101 certification, the company performs a comprehensive internal readiness check, including a full internal audit and a management review, to clarify that the Healthcare Management Quality System is effectively implemented and fully prepared for the external certification audit.
2- Application & Application Review
Secondly, we receive your application and review your organization’s scope, activities, and requirements to confirm eligibility and prepare the appropriate ISO 7101 certification pathway
3- Program Development
Then, we establish the ISO 7101 certification program, including audit duration, audit cycle, required audit activities, and resources based on your organization’s size and complexity.
4- Audit Planning
Subsequently,our audit team prepares a detailed audit plan outlining the audit schedule and processes to be assessed, team responsibilities, and logistical arrangements to ensure a smooth audit process.
5- Stage 1 Audit - Documentation Review
Then, our auditors review your Healthcare Management Quality System documentation to ensure compliance with ISO 7101:2023 requirements and readiness for the main audit.
6- Stage 2 Audit - Certification Assessment
Next We conduct a thorough on-site audit examining implementation of Healthcare Management Quality processes, and evidence of continual improvement, effectiveness of the management system, and compliance with documented procedures.
7- Certificate Issuance
Finally, upon successful completion, TUV United Arabia issues ISO 7101:2023 certificate, valid for three years, demonstrating your innovation capability to stakeholders
8- Ongoing Support & Surveillance
Moreover, we provide continuous support including annual surveillance audits, recertification every three years, and additional training as needed to maintain compliance
Timeline: Complete certification in the shortest possible time from readiness to certificate issuance
Why Choose TUV United Arabia for ISO 7101 Certification?
Practical, Business-Focused Approach:
We focus on building real Healthcare capability that drives business results, not just achieving certification. Our approach balances requirements compliance with practical implementation.
Rapid ISO 71001 Certification:
We understand the urgency of business needs. Therefore, our efficient process enables ISO 71001 certification quickly without compromising audit quality.
20+ Years Combined Expertise:
Our team of experienced auditors brings over 20 years of combined experience certifying organizations across governmental, industrial, and service sectors in Saudi Arabia. Furthermore, this diverse expertise ensures reliable and professional audits.
Competitive Pricing – 20% Below Market:
We offer transparent and competitive pricing approximately 20% below market rates, thus making Healthcare certification accessible to organizations of all sizes.
Comprehensive Support Beyond Certification:
We provide gap analysis, implementation guidance, staff training, and ongoing post-certification support to ensure your continued compliance and improvement. Additionally, our support helps maintain long-term system effectiveness.
Nationwide Coverage:
Based in Riyadh, we serve organizations across all regions of Saudi Arabia including Jeddah, Dammam, Khobar, Makkah, Medina, and beyond. Likewise, our services reach clients in remote areas across the Kingdom.
Frequently Asked Questions
With TUV United Arabia, organizations can achieve ISO 7101 certification as quickly as possible; moreover, the process spans from audit readiness to certificate issuance.
Certification costs vary based on organization size, complexity, and number of sites; therefore, contact us for a customized quote. Additionally, our pricing is approximately 20% below market rates.
However ISO7101 is not legally mandatory for all sectors, ISO 7101 is often required for government tenders and and contracts; moreover, it is essential for demonstrating a commitment to Healthcare Management Quality to customers.
ISO 7101 certificates are valid for three years; moreover, annual surveillance audits are required to maintain certification.
Absolutely, ISO 7101 is scalable and, therefore, applicable to organizations of all sizes, from small businesses to large corporations.
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